Sr. Quality Engineer in Paso Robles, CA at Volt

Date Posted: 4/26/2018

Job Snapshot

Job Description

Volt Workforce Solutions is currently seeking a Quality Assurance Engineer! We have partnered with a medical manufacturing facility in Paso Robles!  

Essential Duties and Responsibilities:

Duties Includes the following (other duties may be assigned or removed upon requirement):

•         Performs internal quality system audits as lead auditor, including establishing audit plans and writing audit reports.

•         Maintains customer complaint (CC) system per procedures. Performs investigations, determines disposition of returned goods, determines reinspection requirements, determines corrective and preventive actions, issues complaint reports, completes customer corrective and preventative actions (CAPAs), and approves to close. Looks for trends to determine actions to decrease number of CCs.

•         Maintains Non-Conforming Material Report (NCMR) system per procedures. Performs investigations, leads material review board (MRB) activities, determines disposition, determines reinspection requirements, CAPAs, and approves to close. Looks for trends to decrease number of NCMR’s and provides feedback to management.

•         Maintains corrective and preventive action system per procedures. Initiates CAPA’s, perform root cause analysis, implement CAPAs. Identifies trends.

•         Performs trend analysis and issues periodic report on quality systems for management review as requested.  Makes recommendations for change when needed.

•         Adheres to the company’s Quality System (QS), writes and approves QS documents, initiates improvements.

•         Conducts investigative work to solve quality problems including statistical and capability analysis. 

•         Provides expertise working with company engineering, manufacturing, and inspection personnel on procedural problems involving design, methods, tooling, validations, costs, and other areas related to the control of product quality.

•         Communicates with customers to successfully resolve issues, complaints and document plans.

•         Uses Lean Enterprise methods to reduce waste and complexity in all processes.

•         Supervises QA department technicians and QC inspectors, if applicable.

•         Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs.

•Writes and approves protocols and reports.

•Approves Equipment Qualifications.

•Develops project plans and schedules to lead medium to large size projects with definable objectives and due dates.

•Provides expertise in all aspects of QA: calibration, incoming materials, document control, QC, bioburden testing, particulate counts.

•Leads customer audits. Participates in ISO audits.

•Trains company personnel as needed in areas such as use of equipment, inspection methods, statistical methods, processes, and quality system.

•Develops and implements six sigma and lean methods to drive improved process and quality.

•Conducts studies including GaugeR&R’s to develop inspection methods and test equipment.

  • Acts as integral member of the Quality Administration group, in support of the defined Quality Administration and SSF Company mission, vision, values, and goals.

  • Shares professionally related talents with colleagues or staff within the company.

  • Performs all other duties and responsibilities that are reasonably assigned from time to time by the employer or its designated representative.

Knowledge, Skills and Abilities:

  • Critical thinking and problem solving skills
  • Strong verbal and written communication
  • Experience with lean manufacturing principles and their implementation
  • Computer competence in using programs such as Microsoft Word, Excel, PowerPoint, Access, JMP
  • Comprehensive understanding of SOP's, ISO standards, and QAP's. 

Minimum Job Qualifications:

•         Bachelor’s degree in Engineering or any relevant technical or science degree, or equivalent experience.

•         9-14 years of manufacturing industry experience, prefer experience in medical silicone or a related industry.